Determination of MCG Reference Intervals in Healthy Individuals

NCT ID: NCT06198777

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2396 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2024-12-31

Brief Summary

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Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting cardiac abnormalities. However, the results of MCG cannot be evaluated without defined reference intervals. This is a multicenter cross-sectional study designed to establish reference values for MCG parameters healthy adults in China.

Detailed Description

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Conditions

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MCG Reference Intervals Determination for Healthy Adults Health, Subjective

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy adults

Magnetometer

Intervention Type DEVICE

Inspection equipment for magnetocardiography

Interventions

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Magnetometer

Inspection equipment for magnetocardiography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older.
2. Those with no hospitalization for any reason in the 6 months prior to the study.
3. Those who are not currently taking any prescribed medications.
4. Those with no history of cardiovascular diseases, including coronary artery disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic coarctation, or peripheral arterial disease.
5. Those with no risk factors for cardiovascular diseases, including hypertension, diabetes mellitus, hyperlipidemia.
6. Those with no history of smoking (previous non-smoking or smoking cessation \>6 months).
7. Those with no excessive alcohol consumption (average daily alcohol consumption \<3 drinks, 1 drink = beer 355mL / white wine 44mL / red wine 118mL).
8. Signed informed consent.

Exclusion Criteria

1. Those with body mass index \>28kg/m2 or \<18kg/m2.
2. Those with resting heart rate \<50 beats/min, or \>110 beats/min.
3. Those with resting systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90 mmHg.
4. Those with fasting blood glucose ≥7 mmol/L, and/or random blood glucose ≥11.1 mmol/L.
5. Those with total cholesterol ≥6.2 mmol/L or low-density lipoprotein cholesterol ≥4.1 mmol/L.
6. Those with abnormal electrocardiograms, such as arrhythmias, ST-T changes, and pathologic electrical axis deflections.
7. Those with cardiac ultrasonographic pathologic findings, such as left ventricular hypertrophy, left ventricular dilatation, abnormal ventricular wall motion, and valvular regurgitation or stenosis of more than mild degree.
8. Those with respiratory diseases, kidney diseases, liver diseases, endocrine diseases, anaemia or other blood diseases, connective tissue diseases, malignant tumors and other diseases.
9. Professional athletes, pregnant or lactating women, psychological or psychiatric disorders such as depression.
10. Those who are unable to perform magnetocardiography due to claustrophobia, etc., or those who are unable to cooperate with the corresponding examinations required by the study for various reasons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Linyi People's Hospital

OTHER

Sponsor Role collaborator

Weifang People's Hospital

OTHER

Sponsor Role collaborator

Jining First People's Hospital

OTHER

Sponsor Role collaborator

Weihai Central Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

Chongqing Emergency Medical Center

OTHER

Sponsor Role collaborator

Heze Municipal Hospital

OTHER

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuguo Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Qliu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiaojiao Pang, Doctor

Role: CONTACT

0086-0531-82165674

Facility Contacts

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Jiaojiao Pang, Doctor

Role: primary

0086-0531-82165674

Other Identifiers

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MCG-healthy

Identifier Type: -

Identifier Source: org_study_id

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